On June 20, 2017, FDA issued the document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Guidance for Industry DRAFT GUIDANCE.
The goals of this guidance are as follows:
• Update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations
• Clarify and further expand on the risk-based approach described in the 2003 part 11 guidance to validation, audit trails, and archiving of records
• Encourage and facilitate the use of electronic records and systems to improve the quality and efficiency of clinical investigations
Click here to view the document.